Diclofenac Sodium
NDC Package 45865-237-01
Package Information
Diclofenac Sodium is diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-237 and is authorized under FDA application ANDA206298.
Identification & Billing
- RxCUI: 855642 - diclofenac sodium 3 % Topical Gel
- RxCUI: 855642 - diclofenac sodium 0.03 MG/MG Topical Gel
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 45865 - Medsource Pharmaceuticals
- 45865-237 - Diclofenac Sodium
- 45865-237-01 - 100 g in 1 TUBE
- 45865-237 - Diclofenac Sodium
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 45865-237-01 identifies a specific commercial package of 100 g in 1 tube of Diclofenac Sodium, labeled by Medsource Pharmaceuticals. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Medsource Pharmaceuticals on April 28, 2016. The current certification is valid through December 31, 2025.
What are the primary indications for this medication?
Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
How is this Medsource Pharmaceuticals product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865023701. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.